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ustekinumab (Absimky / DMB 3115 / DA3115)

✓ Approved

Meiji Seika Pharma Co., Ltd. · IL12B · Monoclonal Antibodies

What is ustekinumab?

ustekinumab is a monoclonal antibodies developed by Meiji Seika Pharma Co., Ltd.. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesAbsimky, DMB 3115, DA3115
CompanyMeiji Seika Pharma Co., Ltd.
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetIL12B, IL23A
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Meiji Seika Pharma Co., Ltd.

Mechanism of Action

Molecular Targets

ustekinumab acts on 2 molecular targets:

IL12Binterleukin 12B (CLMF2, CLMF)
IL23Ainterleukin 23 subunit alpha (P19, SGRF)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

ustekinumab is developed for 4 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
Skin and subcutaneous tissue disordersPsoriasis✓ Approved
Gastrointestinal disordersColitis ulcerative✓ Approved
Gastrointestinal disordersCrohn's disease✓ Approved
Musculoskeletal and connective tissue disordersPsoriatic arthropathy✓ Approved

Related Research Articles

PubMedCancers2026-10-16

Advanced Therapies for the Management of Immune Checkpoint Inhibitor-Induced Colitis.

Matichecchia Cosimo Simone CS, Fanizzi Fabrizio F, Zilli Alessandra A, Ferrara Roberto R et al.

Immune checkpoint inhibitors (ICIs), including anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents, have revolutionized cancer therapy by enhancing T-cell-mediated antitumor responses and significantly improving survival across multiple malignancies. Despite these advances, ICIs are associated with immune-related adverse events (irAEs), with ICI-induced colitis representing one of the most common and severe gastrointestinal toxicities. Clinically and histopathologically, this condition often resembles inflammatory bowel disease (IBD) and can substantially impact treatment continuity and patient quality of life. Corticosteroids remain the standard first-line therapy; however, up to one-third of patients exhibit steroid-refractory disease or develop significant steroid-related toxicity, highlighting the need for alternative therapeutic strategies. Biologic agents, particularly infliximab and vedolizumab, have demonstrated high efficacy in this setting, with infliximab associated with more rapid symptom control and vedolizumab offering a favorable steroid-sparing profile. In patients with multi-refractory disease, additional agents such as ustekinumab, tofacitinib, and tocilizumab have shown promise, although current evidence is limited and primarily derived from small studies and case series. This review critically examines current treatment paradigms for ICI-induced colitis, focusing on efficacy, safety, and potential implications for oncologic outcomes. Despite increasing use of advanced therapies, clinical decision-making remains largely guided by retrospective data, and key uncertainties persist regarding optimal treatment sequencing, patient selection, and long-term safety. Future research should prioritize prospective randomized trials incorporating both oncologic and gastrointestinal endpoints, as well as mechanistic studies aimed at identifying predictive biomarkers and therapeutic targets that preserve anti-tumor immunity.

PMID 42882803
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PubMedFrontiers in medicine2026-10-15

Clinical case series: Emergence of psoriatic arthritis during biologic IL-23 pathway inhibition therapy for psoriasis.

Li Andrew Z AZ, Cooley Ian D ID, Craig Ethan E, Derk Chris T CT et al.

Psoriasis (PsO) and psoriatic arthritis (PsA) are increasingly recognized as manifestations within the spectrum of psoriatic disease, and emerging observational data suggest that biologic therapy targeting interleukin-23 (IL-23) may reduce the risk of incident PsA. This finding remains controversial given the potential for channeling and information bias. Here, we describe five patients with long-standing PsO who developed new-onset PsA while achieving excellent skin clearance with IL-23 or IL-12/23 inhibitor therapy (risankizumab in four patients and ustekinumab in one). The time from the initiation of IL-23 pathway inhibition to PsA diagnosis ranged from 5 to 63 months. All patients met the ClASsification criteria for Psoriatic ARthritis, with musculoskeletal manifestations including dactylitis, synovitis, tenosynovitis, and enthesitis, and two patients had erosive changes on imaging. Joint symptoms improved in the majority of patients after transition to an IL-17-targeted biologic. These cases indicate that IL-23 pathway inhibition may not reliably prevent the onset of PsA and may contribute to its development in susceptible individuals. Thus, this series underscores the importance of ongoing musculoskeletal surveillance in patients with PsO receiving IL-23-targeted therapy, even when skin disease is completely controlled.

PMID 42876761
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PubMedFrontiers in pharmacology2026-10-15

Monoclonal antibodies associated IgA nephropathy or other nephropathies.

Miedziaszczyk Miłosz M, Kosiorowski Gracjan G, Kubasik Janusz J, Grabowski Tomasz T et al.

The use of monoclonal antibodies (mAbs) has revolutionized the treatment of autoimmune, inflammatory, and neoplastic diseases. However, accumulating evidence indicates that biologic therapies may be associated with renal adverse events, including various types of glomerulonephritis. The aim of this review was to summarize all reports available in the scientific literature regarding the occurrence of IgA nephropathy after monoclonal antibody treatment. Additionally, the risk of other glomerulonephritis after biologic therapy was discussed. IgA nephropathy (IgAN) is the most commonly reported glomerular lesion associated with monoclonal antibody therapy, particularly with TNF-α inhibitors such as infliximab, adalimumab, golimumab, and etanercept, as well as with immune checkpoint inhibitors targeting the PD-1 (pembrolizumab, nivolumab) and interleukin (ustekinumab) pathways. Proposed mechanisms include immune dysregulation with a shift toward Th2 and Th17-dependent responses, increased production of galactose-deficient IgA1, complement activation, formation of circulating immune complexes, and loss of immune tolerance. In some cases, drug discontinuation and glucocorticoid therapy have resulted in partial or complete disease remission, although progression to end-stage renal disease has also been reported. Due to the potential severity of these complications, initial and periodic monitoring of renal function and urinalysis are recommended in patients receiving monoclonal antibody therapy. Early recognition of renal involvement and prompt treatment modification can improve prognosis.

PMID 42876810
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PubMedFarmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria2026-10-14

Real-world adherence to biologic therapies targeting interleukin 17, interleukin 23 and ustekinumab in moderate-to-severe psoriasis: A multicenter cohort study.

Calvo-Arbeloa María M, Miguel-Elcano Ramón San RS, Arrondo-Velasco Amaya A, Sarobe-Carricas Maite M et al.

Biologic therapies targeting interleukin IL-17, IL-23 and IL-12/23 have substantially improved outcomes in patients with moderate-to-severe psoriasis. In real-world settings, treatment effectiveness depends not only on drug efficacy but also on patient adherence, which is essential for the appropriate interpretation of treatment persistence. The objectives of the present study were to evaluate adherence to biologic therapy with IL-17 inhibitors, IL-23 inhibitors and IL-12/23 inhibitors in patients with moderate-to-severe psoriasis in real-world clinical practice and to identify factors associated with high adherence. A retrospective, multicenter observational study was conducted in one tertiary hospital and two regional hospitals within the same regional public healthcare system. Adult patients with moderate-to-severe psoriasis treated with IL-17 inhibitors, IL-23 inhibitors or IL-12/23 inhibitors for at least 4 months were included. Adherence was assessed using the medication possession ratio (MPR), calculated as the mean adherence across all dispensations recorded between December 2009 and October 2025. Multivariable logistic regression (with patient-level clustering to account for repeated courses) identified factors associated with excellent adherence (MPR ≥90%). A total of 423 patients and 626 treatment courses were included. Mean overall adherence was 94.5%. Adherence ≥80% was observed in 97.4% of treatment courses, and 78.8% achieved adherence ≥90%. Older age, female sex and treatment with IL-23 inhibitors were independently associated with excellent adherence. Adherence to biologic therapies targeting interleukin IL-17, IL-23 and IL-12/23 in patients with moderate-to-severe psoriasis managed in hospital settings for at least 4 months is very high. Systematic assessment of adherence is essential for interpreting clinical outcomes and is essential for persistence analyses.

PMID 42875349
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PubMedClinical nutrition (Edinburgh, Scotland)2026-10-13

Reply to the letter to the editor: 'comment on "synergistic effects of partial enteral nutrition combined with ustekinumab in Crohn's disease"'.

Wang Biyao B, Zeng Yuan Y, Yang Qingfan Q

PMID 42863420
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PubMedJournal of pediatric gastroenterology and nutrition2026-10-13

Clinical characteristics and treatment outcomes in pediatric microscopic colitis: A retrospective 13-year experience.

Camhi Stephanie S, Jebb Kamryn K, Kleinman Kendall K, Kenyon Victoria V et al.

Microscopic colitis (MC) is a histological inflammatory disease of the colon, commonly diagnosed in adults and known to be associated with autoimmune conditions. Clinical presentation and treatment outcomes in pediatrics are not well described. The aim of the current study was to describe pediatric MC cases encountered at a single center over a 13-year period. We performed a retrospective chart review of patients aged 18 years and younger (inclusive) evaluated in our health system between 2013 and 2025 for MC. Thirty-five patients (80% female) with an average age of 14.2 years at MC diagnosis were included. Presenting symptoms were chronic diarrhea, abdominal pain, and weight loss. Histologically, most patients had lymphocytic colitis (74%), and seven patients (20%) had concurrent celiac disease (CeD). At diagnosis, no patients had elevated systemic inflammatory markers and fecal calprotectin (tested in 26% of patients) was elevated in 66%. The most prescribed treatments included Budesonide (77%) and aminosalicylates (34%). Two patients required biologic therapy including Vedolizumab, Ustekinumab, and Adalimumab. A clinical subgroup emerged who showed complete symptomatic response to Budesonide without additional therapy (n = 8), and four patients in this group had CeD. This study adds to the limited pediatric MC literature, including two cases requiring biologic therapy. Fecal calprotectin is presently underutilized but, when tested, was not reliably elevated in the active disease state. Like adults, Budesonide was the most prescribed therapy for pediatric MC and may represent an important first line treatment option due to select patients exhibiting complete symptomatic response.

PMID 42865120
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